BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 24571912 · Received March 11, 2026

    Report

    Report Number
    2955842-2026-15788
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 18, 2026
    Report Date
    May 6, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT YET RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A SYSTEM COMPONENT FAILURE AND WAS RESOLVED BY REPLACEMENT OF THE MTM.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: A3A, A3B, B1, B2, G3, G6, H1, H2, H6, H11. ADDITIONAL INFORMATION: FURTHER INVESTIGATION CLARIFIED, DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY PROCEDURE, MULTIPLE RECOVERABLE FAULTS OCCURRED AFTER THE START OF THE PROCEDURE ASSOCIATED WITH THE MANIPULATION OF THE LEFT ARM AND PROHIBITING ROBOTIC SURGERY, LEADING TO THE CONVERSION TO OPEN SURGERY.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) #2 FOR FAILURE ANALYSIS (FA) EVALUATION. ERRORS CODES WERE CONFIRMED AS HAVING OCCURRED IN THE FIELD, INDICATING THE BLACK AND WHITE FLAT FLEX CABLES (FFCS) FROM EMBEDDED SERIALIZER IN MASTER BASE (ESMB). UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS INSTALLED ONTO THE STANDARD FIXTURE TEST PLATFORM (SFTP) WHERE THE SINE CYCLE TEST WAS FOUND TO BE FAILING ON THE MTM. ONCE TESTING WAS COMPLETED, THE BLACK AND WHITE FFCS WERE ABA TESTED AND WERE VERIFIED TO BE THE SOURCE OF THE FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THAT THE SYSTEM EXPERIENCED A MALFUNCTION IN THE SURGEON SIDE CONSOLE (SSC) MASTER TOOL MANIPULATOR LEFT (MTML) AT THE VERY BEGINNING OF THE PROCEDURE. EVEN AFTER RESTARTING THE SYSTEM, THE MALFUNCTION PERSISTED, LEADING THE MEDICAL TEAM TO CONVERT THE PROCEDURE TO LAPAROSCOPY. THE TSE WAS NOT CONTACTED WHEN THE PROBLEM OCCURRED, AND AFTER THE PROCEDURE WAS COMPLETED, THE TSE ASKED THE CUSTOMER TO SHUT DOWN THE SYSTEM, MOVE THE MTML, PERFORM AN EMERGENCY POWER OFF (EPO), AND THEN RESTART THE SYSTEM. WHEN THE SYSTEM WAS RESTARTED, THE FAILURE DID NOT OCCUR. THE TSE CHECKED THE LOGS AND IDENTIFIED FAILURES 25517 AND 25521. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113436 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-16 N/A 00886874115374

    Patients

    Seq Age Sex Outcome Treatment
    1